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By George Sale, George Psalmanazar, Archibald Bower, George Shelvocke, John Campbell and John Swinton.

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In this case, other sources of revenue might include enrolling in better-funded industry-sponsored trials or affiliating with organizations that bring in money from clinical care. PAYING FOR PATIENT CARE IN CLINICAL TRIALS 41 General Clinical Research Centers GCRCs are NIH-funded hospital beds set aside specifically for research, which can be used by investigators supported by the NIH, as well as those funded by other public and private agencies. Most GCRC studies are early (phase 1) studies, with intensive medical treatment, monitoring, or both.

The committee commissioned a small study to gather information on this question (Dobson and Sturm, 1999). The Lewin Group interviewed 12 individuals with experience organizing and conducting clinical trials, asking generally about how they PAYING FOR PATIENT CARE IN CLINICAL TRIALS 39 sought reimbursement for enrolled patients. ) In addition, the Lewin Group report summarized a survey of 17 oncology practices conducted for the American Society of Clinical Oncology (ASCO) concerning how they would seek reimbursement for patients treated in a hypothetical clinical trial protocol.

The informed consent process and documentation follow detailed rules set out by the institutional review boards (IRBs) at each site where participants are enrolled. R. §46). The Office for Protection from Research Risks (OPRR) in DHHS is the center for implementing the regulations and providing guidance on ethical issues in biomedical or behavioral research. All responsible host institutions require equivalent procedures, regardless of who is sponsoring the trial. IRBs are charged with protecting human volunteers in biomedical research.

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